FDA Medical devices recall ·
STA - Owren Koller recall
- Recall number
- Z-1993-2025
- Date
- (initiated May 21, 2025)
- Company / brand
- Diagnostica Stago, Inc.
5 Century Dr, Parsippany, NJ, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 939 US ( 2,810 total worldwide)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
STA - Owren Koller. Model/Catalog Number: 00360 STA - Owren-Koller is a buffer solution intended for use as a diluent for reagents and human plasmas in coagulation tests performed with analyzers of the STA-R, STA Compact, STA Satellite and ST art families.
Why was it recalled?
Potential for shorter clotting times in clotting tests which have a dilution, leading to possible overestimate of around 1%
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI: (01)13607450003601(11)240331(17)260331(10)270902(241)00360. Lot Number: 270902.
Distribution
The affected lot was distributed to customers in various US states in October and November 2024. The lot was also distributed in other countries including Canada. The lot was provided to two Distributors in US Territories: MedPharm Corp (Guam) and Isla Lab Products (Puerto Rico); MedPharm will be notified by Stago's Asia-Pacific business unit in the coming days and is not part of this report.
States: Puerto Rico
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1993-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.